Rehabilitation and Enhancement of Vulvovaginal Integrity and Elasticity after Radiation Therapy in Cervical cancer Effect of long and short term application of vaginal dilators on Vulvovaginal Dimensions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 166
- 试验地点
- 1
研究概览
简要总结
Women with cervical cancer are often treated with radiation therapy (with or without chemotherapy). While this treatment improves survival, it can cause long-term side effects in the vagina. Radiation can lead to scarring, narrowing, dryness, and loss of elasticity of the vaginal canal. This condition, called vaginal stenosis, can cause discomfort, pain during sexual activity, emotional distress, and reduced quality of life.
To help prevent these problems, doctors often recommend using a vaginal dilator. A vaginal dilator is a smooth, tube-shaped medical device that is gently inserted into the vagina several times a week. It helps keep the vaginal canal open and flexible by stretching the tissues and preventing scarring from sticking together. Some women are also advised to use a topical estrogen cream to reduce dryness and improve comfort.
However, there is no clear agreement on how long each dilator session should last. Some guidelines recommend 10–15 minutes per session, while others suggest shorter durations. Longer sessions may be difficult for many women to continue regularly, especially in India, where awareness and comfort discussing sexual health can be limited. Because of this, many women may not follow the treatment as advised.
The REVIVE-C Trial is being conducted at the Department of Gynaecologic Oncology, Dr B Borooah Cancer Institute, to compare two different durations of vaginal dilator use in women who have completed radiation therapy for cervical cancer.
The study will include 166 women aged 18 to 70 years who have received radiation for cervical cancer (FIGO stage IB–IVA). Participants will be randomly divided into two groups:
- Group 1 (Standard Duration): Use the vaginal dilator for 10–15 minutes, three times per week.
- Group 2 (Short Duration): Use the vaginal dilator for 1–3 minutes, three times per week.
In both groups, women may use estrogen cream if recommended by their doctor.
The treatment will continue for six months. Doctors will measure vaginal length, width, and elasticity at the beginning and end of the study using simple examination tools. Women will also complete a questionnaire called the EORTC QLQ-CX24 to understand how they feel about their sexual health, comfort, and overall quality of life.
The main goal of the study is to find out whether shorter dilator sessions work just as well as longer sessions in maintaining vaginal health. If shorter sessions are equally effective, they may be easier for women to follow, leading to better long-term compliance and improved quality of life.
This study is important because there is limited research in Indian women on managing vaginal side effects after radiation therapy. The results may help develop practical, culturally suitable guidelines for improving the quality of life of cervical cancer survivors in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- Female
入选标准
- •Women aged 18–70 years with primary, biopsy-confirmed carcinoma of the uterine cervix.
- •FIGO (International Federation of Gynecology and Obstetrics) stage IB–IVA.
- •Patients who have received radiotherapy, either as part of their primary treatment or in the adjuvant setting.
- •Willing to participate in the study.
排除标准
- •Prior radiotherapy for any cancer other than cervical cancer.
- •Contraindications to estrogen therapy, including: oRecent myocardial infarction.
- •oSevere arterial hypertension.
- •oRefractory diabetes mellitus.
- •oHistory of thromboembolism.
- •oDecompensated liver disease.
- •oHistory of breast cancer or mammary dysplasia with atypical hyperplasia.
- •oFamily history of breast cancer.
研究者
Dr Upasana Baruah
Dr. B Borooah Cancer Institute
